Orabloc launch

May 10, 2011
Orabloc is a new purer formulation of Articaine with epinephrine, an injectable dental anesthetic for routine dental procedures and oral surgery.

WAYNE, Pennsylvania--Pierrel Research USA, a subsidiary of Pierrel SpA--the Italian-based, global pharmaceutical services company--has announced the U.S. launch of Orabloc.

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Orabloc (Articaine hydrochloride 4% with epinephrine 1:100,000 and Articaine hydrochloride 4% with epinephrine 1:200,000) is a new purer formulation of Articaine with epinephrine, an injectable dental anesthetic for routine dental procedures and oral surgery.

"With the availability of Orabloc, U.S. dentists will now have a purer choice in Articaine anesthetics," said Canio Mazzaro, chairman, and CEO of Pierrel SpA.

"Up to this point, all available U.S. brands of Articaine are manufactured in Canada using the terminal sterilization method. Pierrel manufactures Orabloc using an aseptic method in our FDA-approved facility in Capua, Italy, and the result is a purer formulation of Articaine. Orabloc is an Articaine with less degradation products and impurities such as articaine acid and epinephrine sulphonic acid. What's more, Orabloc requires less overage of epinephrine, so there is less vasoconstrictor in each injection. Less vasoconstrictor is clearly more desirable and is consistent with recommendations from the American Heart Association to use the lowest available amount of vasoconstrictor."

Mazzaro added, "Orabloc is not only the first aseptically manufactured Articaine available in the U.S., it is one of the few Italian pharmaceutical products approved by FDA in the last 30 years. The approval clearly shows the need and value of Orabloc as its approval in the U.S. is now joined by approvals in Canada, Italy, and Russia with approvals pending in Germany, UK, France, Austria, and Poland."

According to Bernardo Verrengia, scientific and regulatory advisor for Pierrel SpA and a team leader in the development of Orabloc, "Orabloc offers the same rapid onset of action that dentists expect from existing Articaine: anesthesia within one to nine minutes, with complete anesthesia lasting about one hour for infiltrations, up to two hours for nerve block. Additionally, our aseptic manufacturing process provides significantly increased shelf life for Orabloc—up to 24 months at 25°C (77°F), compared to 18 months shelf life for terminally sterilized Articaine.

Orabloc will be available through Patterson Dental, one of the largest dental product distributors in North America.

"We're quite pleased to be working with Patterson on this very important launch," said Michael Laird, RPh, and CEO for Pierrel Research USA.

"Patterson is one of the oldest and most respected dental distributors in the business with $2.2 billion in annual revenue and a huge, loyal dental audience. They have put significant resources behind the launch of Orabloc, including the importation and stocking of sufficient product to meet U.S. demand and the training of their entire dental sales force."

Based on its product profile and the fact that dentists now have more choice, Orabloc could gain a significant share of the $210 million U.S. dental anesthetic market. According to sources, Pierrel is aiming for a 15-20% share within the next few years.

With Patterson's sales force of 1,100 representatives calling on some 80,000 dentists per year, Orabloc could dominate the Articaine segment. If U.S. dentists follow the trend in Europe, it is possible that the Articaine segment could become the preferred dental anesthetic.

Orabloc is scheduled to be launched officially in the U.S. May 12-14, 2011, at the California Dental Association in Anaheim, Calif. A press conference will be held at 6 p.m. May 12 in the Malibu Room at the Hilton Anaheim. Verrengia and Dr. Stuart Lieblich, a published and recognized expert on dental anesthesia and dental surgery, will be presenting.

For more information, go to www.pierrel-research-usa.com.

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